MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-07 for ESTEEM STRETCHY SYNTH CREAM M 8882B manufactured by Cardinal Health.
[21807455]
Technologist reported breaking out in hives to the employee health department. She was examined by a physician and offered cortisone cream. Her reaction began months ago but was progressively getting worse. She is now using nitrile gloves without any problems.
Patient Sequence No: 1, Text Type: D, B5
[21919615]
Cardinal health is filing as the importer. The device history record was reviewed and no abnormalities were noted. Historical trending was done. No sample was provided for evaluation. Based on the retained samples, there is no skin irritation after doing a wearing test. There is no change in the formulation and chemicals. Based on the investigation conducted, there is no abnormality found on the retained samples. Without the actual sample, the root cause cannot be determined. The supplier has been apprised of the complaint for close monitoring of the manufacturing process. We will continue to monitor for complaints of this nature. Notation - the customer stated that her reaction began months ago and did not provide an actual incident date. The cardinal health aware date of (b)(6) 2014 was used as the incident date on this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2014-00010 |
| MDR Report Key | 3667070 |
| Report Source | 05 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-03-07 |
| Date of Event | 2014-02-12 |
| Date Facility Aware | 2014-02-12 |
| Report Date | 2014-02-13 |
| Date Reported to Mfgr | 2014-02-13 |
| Date Mfgr Received | 2014-02-12 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-03-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH 200, LLC |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM STRETCHY SYNTH CREAM M |
| Generic Name | GLOVE, PATIENT EXAMINATION, VINYL |
| Product Code | LYZ |
| Date Received | 2014-03-07 |
| Catalog Number | 8882B |
| Lot Number | 9R13L029 |
| Device Expiration Date | 2016-08-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-07 |